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Although randomized trials have suggested the value of drug eluting stents in a selected group of diabetic patients with "On Label" indications, very little is known about its true role in "Off Label" indications.
Compare Intrahospital and long term outcomes of coronary angioplasty with drug eluting stent in “Off Label” indications, in diabetic patients compared with no diabetic.
255 patients were treated with coronary angioplasty (CA) with drug eluting stent between 31-5 -03 and 28-2-07. 57 patients were diabetic and 159 were no diabetic, both groups were compared. The average follow-up was 22 months (6-45). Both groups were similar, with the exception of the female sex (44% in diabetic and 19.4% in no diabetic P<0.001) and in indications of coronary angioplasty because of drug elutin stent restenosis in diabetic patients: 22% vs. 7.1% in no diabetic patients P< 0.003. The CA was indicated: In diabetic patients vs. no diabetic: ostial lesions: 5% vs. 8.2%, total obstruction: 10.2% vs. 9.7%, bifurcation: 3.3% vs. 4.6%, bare stent restenosis: 13,5% vs 17,3%, drug elutin stent restenosis: 22% vs. 7,1%, average of small vessels: 2,9mm (25-40mm), average of lesion length: 10-50mm (23mm)
| DIABETICOS 57 ptes |
NO DIABETICOS 159 ptes |
|
| Male | 33 (55.9%) | 158 (80.6%) |
| Female | * 26 (44.1%) | 38 (19.4%) |
| Hipertension | 35 (59.3%) | 104 (53%) |
| Dyslipidemia | 21(35%) | 72 (36.7%) |
| Smokers | 20 (33%) | 70 (35.7%) |
| Diabetics | 57 (100%) | 0 |
| Previous Myocardial infarction | 18 (30.5%) | 56 (28.6%) |
| Previous ACTP | 14 (23.7%) | 34 (17.3%) |
| Previous cardiac surgery: | 4 (6.8%) | 11 (5.6%) |
| DIABETICOS | NO DIABETICOS | |
| Left main | 3 (5.1%) | 8 (4.1%) |
| LAD | 37 (62,7%) | 114 (58.2%) |
| Circunflex | 9 (15.3.8%) | 44 (22.4%) |
| Rigth Coronary | 1 (1.7%) | 45 (23%) |
| Diagonal | 15 (4,5%) | 9 (4,6%) |
| Marginal | 0 | 3 (1,5%) |
| DIABETICOS | NO DIABETICOS | |
| Unastable angina | 54 (91.5%) | 185 (94.4%) |
| Stable angina | 5 (8.5%) | 10 (5.1%) |
| DIABETICOS 70 lesions |
NO DIABETICOS 225 lesions |
|
| TIPO A | 1 (1.4%) | 0 |
| TIPO B1 | 2 (2,8%) | 7 (3,I%) |
| TIPO B2 | 9 (12.8%) | 37 (16.4%) |
| TIPO C | 58 (82.8%) | 181 (80.4%) |
| DIABETICOS | NO DIABETICOS | |
| Diameter vessels | 2,5-4.0 (mean 2,9 mm) | 2,5-4.0 (mean 2,9 mm) |
| Lesion length | 10 A 50 (mean 23 mm). | 10 A 49 (mean 22 mm) |
| STENTS | DIABETICOS 70 stents |
NO DIABETICOS 264 stents |
| APOLLO | 1 | 5 (1.8%) |
| COSTAR | 3 | 22 (8.3%) |
| ENDEAVOR | 25 | 80 (30.3%) |
| FIREBIRD | 4 | 25 (9.4%) |
| CYPHER | 10 | 42 (15.9%) |
| TAXUS | 29 | 90 (34%) |
| DIABETIC | NO DIABETIC | |
| Baloon predilatation | 58 ptes (98.3%) | 192 ptes (98.%) |
| Direct stent | 1 pte (1.7%) | 4 ptes (2%) |
| posdilatation | 0 | 2 ptes(1%) |
Results There were no significant differences in the success of the procedure (100% diabetic patients vs. 99.5% no diabetic ones), the survival free of cardiac death and myocardial infarction (100% diabetic patients vs. 98.8% in no diabetic ones), late thrombosis (0% in diabetic vs. 1.2 in no diabetic), cardiac mortality (0% diabetic patients vs. 0.5% in no diabetic), general mortality (1.2% in diabetic ones vs. 2.0% in no diabetic patients).
Survival free of major events was greater in no diabetic patients (89.6% vs. 79.7% in diabetic patients) at the expense of greater revascularization of the target lesion in diabetic patients (20.3% vs. 9.2 % in no diabetic) P> de 0,02.
There were 84.9% asymptomatic patients among the no diabetes vs. 72.9% of diabetic, P>0.03.
The statistic method used was chi 2, with SPSS 12.0 software, taking P as statiscally significant (P=0.05)
| Intrahospital | Follow up (22 month) | |||
| Diabetic | no diabetic | Diabetic | no diabetic | |
| Total death | 0 | 0 | 2 | 3 |
| Cardiac death | 0 | 0 | 0 | 1 (0,5%) |
| AMI | 0 | 1 (0,5%) | 0 | 1 (0,4%) |
| TLR | 0 | 0 | 12 ptes (20.3%) | 18 ptes (9.2%) |
| Revasc ACTP | 0 | 0 | 11 ptes (18.6%) | 13 ptes (6.6%) |
| Revasc surgery | 0 | 0 | 1 pte (1.7%) | 5 ptes (2.6%) |
| Acute trombosis | 0 | 1 (0,5%) | ||
| Late trombosis | 0 | 0 | 0 | 2 (1%) |
Despite the use of drug eluting stents, angioplasty in "Off Label" coronary lesionsin diabetic patients had a worse evolution prospect than in the no diabetic at the expense of a higher rate of revascularization of the target lesion, without statistically significant differences in mortality and myocardial infarction, similar to the published results in literature Trials and Records.
Autor: Dr. Carlos Alejandro Alvarez, Dr. Fernando Ordoñez, Dr. Alberto Cristino, Dr. Carlos J. Alvarez Iorio
Ultima actualizacion: 23 DE JUNIO DE 2008
